Massive Corruption Revealed to be at the Core of Many Drug Approvals

May 03, 2012
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Story at-a-glance

A study has come out showing massive corruption behind drug approvals for drugs that are basically worthless and, too often, end up being dangerous to your health

The latest study includes a review of the antiviral influenza drug Tamiflu (oseltamivir), which was widely recommended as effective based on one published meta-analysis; but when researchers gained access to the raw data of the clinical studies, they realized the drug was being misrepresented and was not effective at all

The report details exactly why it is so important that clinical study reports be fully available for review -- without them, a drug may appear effective and safe when it is anything but

When it comes to your health, you simply cannot accept claims at their face value … you've got to dig below the surface and use all the resources available to you to determine what medical treatment or advice will be best for you in any given situation

By Dr. Mercola

Every day millions of people take medications, both prescription and over-the-counter, trusting that they not only work, but are safe because they've been reviewed and approved by government agencies like the FDA.

But now, yet another study has come out showing massive corruption behind FDA-approved drugs that are basically worthless and, too often, end up being dangerous to your health.

The latest study includes a review of the antiviral influenza drug Tamiflu (oseltamivir), which was pushed on the world during the 2009 influenza pandemic and heralded as THE intervention for the so-called deadly swine flu.

What researchers found in retrospect is that much information that regulators should have known about the efficacy and safety of this drug was either hidden or ignored, making it impossible for independent researchers to scrutinize the big picture.

You Can't Trust a Drug to be Safe and Effective Just Because it's "Approved"

In 2006 health agencies such as the U.S. Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) began warning of the imminent onset of an avian flu contagion of pandemic proportions.

The pandemic never materialized, but sales of Tamiflu, touted as effective in reducing complications of flu such as bronchitis and pneumonia, skyrocketed.

In 2009 it was again presented as the drug of choice to stave off swine flu.

Back in 2006, Dr. Tom Jefferson had issued an analysis concluding that the drug was effective.

But when another physician later pointed out that 8 of the 10 studies he had relied on were still unpublished, Jefferson decided to locate the raw data -- only to find he was unable to do so.

His concern turned to outrage when two employees of a communications company admitted that they had been paid to ghostwrite some of the studies, with explicit instructions to come to the "correct" conclusion regarding Tamiflu's effectiveness. This prompted Dr. Jefferson, of the Cochrane Collaboration, to continue seeking the raw data of the trials, which completely changed his original conclusions. According to the Los Angeles Times:i

"After reanalyzing the raw data finally made available (they still don't have it all) ... there was no proof that Tamiflu reduced serious flu complications like pneumonia or death. In short, it appears the pharmaceutical companies had been ... conning the public on matters of health..."

Now, Dr. Jefferson and colleagues have released a report detailing exactly why it is so important that clinical study reports be fully available for review. Without them, a drug may appear effective and safe when it is anything but… They wrote in the journal PLoS Medicine:ii

"In 2010, we began our Cochrane review update using clinical study reports rather than published papers. We obtained some sections of these clinical study reports for the ten trials appearing in the Kaiser 2003 meta-analysis from Tamiflu's manufacturer, Roche—around 3,200 pages in total.

In 2011, we obtained additional sections of clinical study reports for Tamiflu through a Freedom of Information request to the EMA [European Medicines Agency], amounting to tens of thousands of pages.

While extensive and detailed, it is important to note that what we have obtained is just a subset of the full clinical study reports in Roche's possession. Nonetheless … This information has turned our understanding of the drug's effects on its head. Other drugs for which previously unpublished, detailed clinical trial data have radically changed public knowledge of safety and efficacy include Avandia, Neurontin, and Vioxx."

Reviewing Only Published Data is Not an Accurate Way to Gauge a Drug's Safety or Effectiveness

Just a few examples of the types of information uncovered about Tamiflu when researchers gained access to full clinical study reports, as opposed to published trial data, include:

Vital details of trials (content and toxicity profile of placebos, mode of action of drug, description and timing of adverse events)

Rationale for alternatively classifying outcomes such as pneumonia as a complication or an adverse event

Realization that serious adverse events (SAEs) occurred in trials for which SAEs were not reported in published papers

This information was enough for the researchers to completely change their opinion of the drug! Unfortunately, government agencies includingthe U.S. Department of Health and Human Services (HHS) and the Advisory Committee on Immunization Practices had already made claims that Tamiflu would cut hospitalizations and save lives. The majority, if not all, of these claims were based on one single source, as researchers noted in PLoS Medicine – "a meta-analysis published in 2003 that combined ten randomized clinical trials conducted during the late 1990s by the manufacturer prior to US registration of the drug."

In order for independent researchers to be able to confirm or refute a drug's safety and/or effectiveness, they need access to the same clinical study reports made available to regulators. If that had happened sooner, researchers may have been able to challenge the use of Tamiflu for swine flu (as well as question why the U.S. had stockpiled nearly $1.5 billion worth of the questionable drug prior to the H1N1 outbreak)! The researchers continued in PLoS Medicine:

"Systematic reviews of published randomized clinical trials (RCTs) are considered the gold standard source of synthesized evidence for interventions, but their conclusions are vulnerable to distortion when trial sponsors have strong interests that might benefit from suppressing or promoting selected data. More reliable evidence synthesis would result from systematic reviewing of clinical study reports—standardized documents representing the most complete record of the planning, execution, and results of clinical trials, which are submitted by industry to government drug regulators.

Dr. Jefferson's final update on Tamiflu was published in December 2009,iii in which he concluded:

"Neuraminidase inhibitors have modest effectiveness against the symptoms of influenza in otherwise healthy adults. The drugs are effective postexposure against laboratory confirmed influenza, but this is a small component of influenza-like illness, so for this outcome neuraminidase inhibitors are not effective. Neuraminidase inhibitors might be regarded as optional for reducing the symptoms of seasonal influenza. Paucity of good data has undermined previous findings for oseltamivir's prevention of complications from influenza. Independent randomised trials to resolve these uncertainties are needed."

U.S. Tightens Rules on Antibiotics Use for Livestock -- But Not Enough to Prompt Real Change

In another example of how the U.S. government favors partnering with industry over the protection of public health, last year the U.S. Food and Drug Administration (FDA) quietly posted a notice in the Federal Register that it was effectively reneging on its plan to reduce the use of antibiotics in agricultural animal feed – a plan it had been touting since 1977.

With virtually no public announcement, the FDA decided it would continue to allow livestock producers to use the drugs in feed, unabated; a move that is threatening food safety by contributing to the spread of new, antibiotic-resistant "super-germs." Then, in January the FDA announced it would restrict the use of one class of antibiotics, cephalosporin, in cattle, swine, chicken and turkey. The antibiotics, which are regularly prescribed to humans, are implicated in the development and spread of drug-resistant bacteria among humans that work with, and eat, the animals. The FDA said that starting April 5, the antibiotics would no longer be allowed for use in preventing diseases in livestock, although they will still be allowed for illness treatment in livestock.

Now, in a move that illustrates how the FDA gives scoundrel drug companies years to NOT legally comply with a regulation before they're forced to by law, a judge has ordered the government to "warn" drug makers that certain antibiotics may soon be banned from agricultural uses. The ruling effectively restarts the process that began 35 years ago but was never completed, The New York Times said.

Following the court's order, the FDA announced that farmers and ranchers are now going to need a prescription to use the drugs with their animals. Industrial farming supporters called the move the most sweeping action the FDA has ever taken, but it fell under severe criticism by the Center for Science in the Public Interest, which said it is too lax because it basically relies on voluntary industry efforts.

As was the case with Tamiflu, despite evidence that the drugs are causing far more harm than good to the public, the government is failing to take action against them. As written in The New York Times:iv

"The FDA is expected to issue draft rules within days that ask drug makers to voluntarily end the use of antibiotics in animals without the oversight of a veterinarian. But neither the judge's order nor the FDA's expected rule changes are likely to fundamentally alter the large-scale agricultural uses of antibiotics because farmers and ranchers now say the drugs are being used to prevent animal diseases, not to promote growth. "

Tips to Look Out for Your Health and Safety

Increasing numbers of people are now waking up to the harsh realities that oftentimes drugs are released to the market without being proven safe or effective. Remember that the definition of fascism is a government system that has complete power in regimenting all industry and forcibly suppressing opposition and criticism. What we have here is a hybrid—a sort of corporate fascism, where industry has powerful control over government, and forcefully suppresses anything that threatens their monopoly on profits.

Unfortunately, this can be extremely dangerous as it pertains to your health.

Virtually every measurable index indicates that despite the ever-increasing amounts of money invested, if you live in the United States your chance of achieving optimal health through the medical system is only getting worse. This is why, when it comes to your health, you simply cannot accept claims at their face value … you've got to dig below the surface and use all the resources available to you, including your own commonsense and reason, true independent experts' advice and other's experiences, to determine what medical treatment or advice will be best for you in any given situation.

Ultimately, you must come to the realization that YOU are responsible for your, and your family's health -- not me, not your physician, and certainly not any researchers or government health agencies that are beholden to the drug industry.